NCT02678611

CompletedPhase 1

A Study to Evaluate Safety and Health Benefits of Basis™ Amo...

Elysium Health Source

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Other study identifiers

Sponsor study identifier

15BSHE

Study Type

interventional

Actual enrollment (reported)

120

Locations

1 country

Sites

1

Timeline

Study Start

January 2016

Date type not reported

This date has not been verified as actual or estimated.

Primary Completion

July 2016

Actual (reported)

Study Completion

Not reported

Date not reported

Brief Summary

This study will investigate the safety, tolerability and potential health benefits of the dietary supplement, Basis. There will be two doses of Basis compared to a placebo. One third of subjects will receive the low dose Basis, one third will receive the higher dose Basis and one third will receive placebo.

Registry Overview

Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.

Recruitment status: completed
Actual enrollment (reported): 120 participants
Study completion date: Not reported
Date not reported
Listed locations: 1 countries · 1 sites

Trial Relationships

Click on a node to explore related trials.

Some registry-reported names shown below are not yet linked in this graph.

Study Timeline

Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.

Study Start
January 2016
Date type not reported
This date has not been verified as actual or estimated.
First Submitted
February 3, 2016
Actual (reported)
First Posted
February 10, 2016
Actual (reported)
Primary Completion
July 2016
Actual (reported)

Last Updated: August 1, 2016
Status Verified: July 2016
Last Update Submitted: July 28, 2016

Conditions

Safety: Healthy Subjects

Keywords

Healthy participantsDietary supplementSafetyTolerabilityOlder AdultsBasisNicotinamide ribosidePterostilbene

Outcome Measures

Primary Outcomes (3)

Blood pressure
Assessment of blood pressure
8 weeks
Safety Blood Parameters
Assessment of safety blood parameters: CBC, electrolytes (Na, K, Cl), kidney function (creatinine), liver function (AST, ALT, GGT and bilirubin)
8 weeks
Heart Rate
Assessment of heart rate
8 weeks

Secondary Outcomes (10)

Physiological Performance
8 weeks
Physiological Performance
8 weeks
Physiological Performance
8 weeks
Body Weight
8 weeks
Blood Pressure
8 weeks
+5 more secondary outcomes

Other Outcomes (3)

Expression Profile of Peripheral Blood Mononuclear Cells
8 weeks
Pain Assessment
8 weeks
Endothelial Function
8 weeks

Study Arms (3)

Basis 250

EXPERIMENTAL

Dietary Supplement: Basis 250

Basis 500

EXPERIMENTAL

Dietary Supplement: Basis 500

Placebo

PLACEBO COMPARATOR

Dietary Supplement: Placebo

Interventions

Basis 250Dietary supplement

Basis 250

Basis 500Dietary supplement

Basis 500

Placebo

Eligibility Criteria

Age60 Years - 80 Years

Sexall

Healthy VolunteersYes

Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

Males or females 60 to 80 (inclusive) years of age
Body Mass Index (BMI) must be 18 to 35 kg/ m2 (±1 kg/m2)

Sponsors & Collaborators

Elysium Health
Industrylead
KGK Science Inc.
Industrycollaborator

Study Sites (1)

KGK Synergize Inc.

London, Ontario, N6A 5R8, Canada

Study Officials

Tetyana Pelipyagina, MD
KGK Science Inc.
PRINCIPAL INVESTIGATOR

Enrollment

120 participants (actual enrollment reported by the registry).

Study Design

Study Type: interventional
Phase: phase 1
Allocation: RANDOMIZED
Masking: QUADRUPLE
Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Intervention Model: PARALLEL
Sponsor Type: INDUSTRY
Responsible Party: SPONSOR

Study Record Dates

First Submitted

February 3, 2016

First Posted

February 10, 2016

Study Start

January 2016

Date type not reported

This date has not been verified as actual or estimated.

Dietary supplement

Placebo

Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.

Be able to make scheduled office visits 4 times during the study

Willing to follow the instructions and complete multiple study questionnaires and assessments

Agrees to avoid taking Vitamin B3 (Niacin, Nicotinic acid or niacinamide) supplements or multivitamins 14 days prior to randomization and for the duration of the study period

Healthy otherwise as determined by laboratory results and medical history

Has given voluntary, written, informed consent to participate in the study

You may not qualify if:

History of any significant chronic disease or any clinically active illness within 3 months of study entry, including any history of renal or liver impairment, any endocrine, inflammatory, cardiovascular, gastro-intestinal, neurological, psychiatric, neoplastic or metabolic disease. Clinical significance of disease will be assessed by the Qualified Investigator and eligibility determined.
Significant or untreated medical disorders including recent myocardial ischemia or infarction, unstable angina, uncontrolled hypertension, AIDS, malignancy, epilepsy, and recent cerebrovascular disease
Subjects with or who have recently experienced a traumatic injury, infections or undergone surgery
Subjects with history of pellagra or niacin deficiency
Taking lipid lowering drugs
Use of natural health products containing Nicotinamide riboside within 14 days prior to randomization and during the course of the study
History of or current diagnosis of any cancer (except for successfully treated basal cell carcinoma) diagnosed less than 5 years prior to screening. Volunteers with cancer in full remission more than 5 years after diagnosis are acceptable
Has participated in any clinical trial with an investigational medicinal product within the past three months prior to the first dose in the current study
Unstable medical conditions
Alcohol use \>2 standard alcoholic drinks per day
History of alcoholism or drug abuse within 1 year prior to screening
History of significant allergies
Allergy or sensitivity to any of the investigational product ingredients
Use of medicinal marijuana
Clinically significant abnormal laboratory results at screening
+2 more criteria

Contact the study team to confirm eligibility.

Primary Completion

July 2016

Actual (reported)

Last Updated

August 1, 2016

Record last verified: 2016-07

Source record

Download the complete ClinicalTrials.gov record imported by Syfrah, including fields not shown in this page. The registry may contain a newer revision.

Source: ClinicalTrials.gov.

JSON downloads include source attribution and retrieval details alongside the unchanged original record or the separately normalized values.

Registry identifier: NCT02678611
Data provider: ClinicalTrials.gov
Source updated: 2016-08-01
Normalization version: ctgov-legacy-1

Open registry record

Source retrieved: 2026-10-25 22:35:04 UTC

Locations

CA(1)

Brief Summary

Registry Overview

Trial Relationships

Related Scientific Literature

Study Timeline

Study Start

First Submitted

First Posted

Primary Completion

Conditions

Keywords

Outcome Measures

Primary Outcomes (3)

Secondary Outcomes (10)

Other Outcomes (3)

Study Arms (3)

Basis 250

Basis 500

Placebo

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (1)

Study Officials

Enrollment

Study Design

Study Record Dates

You may not qualify if:

Source record

Locations